The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients

Completed

Conditions studied: HIV Infections

In brief

The purpose of this study is to see how taking certain anti-HIV drugs affects the way the body metabolizes fat. This study will evaluate patients who are enrolled in CPCRA 058 (the FIRST \[Flexible Initial Retrovirus Suppressive Therapies\] study) by looking for changes in cholesterol levels, levels of fat in the blood, and body fat distribution. Patients in the FIRST study receive an anti-HIV drug regimen which contains a protease inhibitor (PI), a nonnucleoside reverse transcriptase inhibitor (NNRTI), or both. Anti-HIV drug therapy using PIs has become very common treatment for HIV-positive patients. Recently, however, serious side effects involving how the body uses fat are being reported in patients taking PIs. Examples of these side effects are a redistribution of body fat, high cholesterol level, and development of diabetes. However, some of these side effects have also been seen in patients who are not taking PIs. It is important to determine whether or not these side effects are directly related to PI use. In this study, patients on different drug combinations, either with or without a PI, will be compared.

Key facts

Study ID

NCT00001102

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

460

Expected to finish

2006-06-01

Last updated by the study team

2014-04-17

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are enrolled in the FIRST study (CPCRA 058).
• Have written informed consent of parent or guardian if under the age of 18.

Where it is running

• Community Consortium / UCSF — San Francisco, California, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• Washington Reg AIDS Prog / Dept of Infect Dis — Washington D.C., District of Columbia, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• Wayne State Univ - WSU/DMC / Univ Hlth Ctr — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Southern New Jersey AIDS Cln Trials / Dept of Med — Camden, New Jersey, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Partners in Research / New Mexico — Albuquerque, New Mexico, United States
• Harlem AIDS Treatment Grp / Harlem Hosp Ctr — New York, New York, United States
• The Research and Education Group — Portland, Oregon, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Richmond AIDS Consortium / Div of Infect Diseases — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.